About this trial
Hereditary spastic paraparesis is a group of inherited neurological diseases. Only symptomatic treatments exist for the moment. The Modifspa study (cf citation) carried out by the team showed that patients perceived a feeling of effectiveness of physiotherapy on lower limb spasticity. The aim of the Walk-up study is to objectivize this feeling of efficacy on gait disorders in these patients.
This is an interventional study using physical training. The study is prospective, open, randomized in 2 parallel groups, one of which is a control group. Analyses will be comparative between the 2 groups during the course of the study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient with molecular diagnosis of hereditary spastic paraparesis based on pathogenic variant of SPAST gene,
Walking possible for 6 minutes without human assistance (one or more technical aids are authorized: e.g. cane, walker, orthoses),
At least 1 physiotherapy session per week already in place.
Understanding of the protocol
Disqualifiers
Botulinum toxin injection within 2 months of protocol inclusion
Discontinuation of private physiotherapy,
Refusal to participate in the protocol,
Participation in another interventional clinical trial evaluating a health product or in a randomized clinical trial
Trial design
Parallel
Treatments tested in this trial
intensive reeducation
Other intervention* 1 group physiotherapy session per week at the ICM or by videoconference from home for 6 weeks * 2 sessions per week at home with video support sent by e-mail for 6 weeks
Treatment groups
Trial outcomes
Primary outcomes
to compare the before-and-after variation in distance covered in 6 minutes between the intensive physical rehabilitation group and the control group.
6-minute walk test carried out in the presence of a clinician trained in this test. The patient walks for 6 minutes on a circuit of known distance, identical for each patient. The clinician times the walking time and measures the distance covered during 6 minutes. This test is performed at inclusion and again at 6 weeks
Secondary outcomes
compare the before-after variation in distance covered in 6 minutes
6-minute walk test carried out in the presence of a clinician trained in this test. This test is performed at inclusion and again at 18 weeks
compare the before-after variation in walking speed over a 10-meters test
10-meters test carried out in the presence of a clinician trained in this test. This test is performed at inclusion and again at 18 weeks
compare the clinical evolution of spasticity
clinical evolution of spasticity using Spastic Paraplegia Rating Scale (SPRS)
compare the lower-limb joint amplitudes
clinical evolution of lower-limb joint amplitudes using the modified Aschworth scale
Sponsors and contacts
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